Title
Study to Evaluate Effect of Pandel Cream 0.1% on HPA Axis in Pediatric and Adult Population
An Open -Label Study to Evaluate the Effect of Pandel Cream 0.1% on the Hypothalamic Pituitary Adrenal Axis in the Pediatric and Adult Population
Phase
Phase 4Lead Sponsor
FougeraStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Psoriasis Atopic DermatitisIntervention/Treatment
urea ...Study Participants
19The purpose of this study is to determine the effect of Pandel® (hydrocortisone probutate cream) Cream 0.1% on the Hypothalamic Pituitary Adrenal (HPA) axis in pediatric and adult subjects with either psoriasis or atopic dermatitis involving greater than 20% body surface area.
A thin coat of cream will be applied and rubbed into the affected areas, as well as normal skin, twice daily for 21 days
Inclusion Criteria: Clinical diagnosis of psoriasis or atopic dermatitis involving more than 20% of body surface area Good health with the exception of psoriasis or atopic dermatitis Exclusion Criteria: Any disease affecting the HPA-axis Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period
| Event Type | Organ System | Event Term | Pandel Cream 0.1% |
|---|
The number of subjects with a post-injection serum cortisol level less than or equal to 18 ug/dL on Day 22.
The number of subjects with pre-injection serum cortisol levels less than or equal to 5 ug/dL Day 22.
